It is well known that various substances can, or must, be packaged for use at a later time and/or place. This is particularly true, for example, with respect to drugs, and various attempts have been heretofore made to package drugs with a view toward overcoming the many problems associated therewith.
Heretofore, it has been quite common, for example, in pre-filled drug packaging, to provide unit doses wherein the entire contents of the prepared package are delivered to the patient with no attempt being made to individualize the dosage.
Known devices and methods for providing and/or utilizing pre-filled drug packages, however, have heretofore required significant manual labor, particularly in administering the contents, even though preparation time was often reduced relative to non-pre-filled packages, and most known packaging for injectable drugs has not been designed for integration with delivery control devices that allow multiple doses to be administered to a patient.
Traditional multi-dose containers have, typically, been intended for reconstitution with diluent and dispensing from separate containers, each of which had to be filled with the drug solution. Normally these containers have been simple bottles using a needle penetration septum, and separate venting has been commonly utilized, such as that provided by self-venting filters or by a separate needle.
While self-venting filters/needles have been intended to allow safe use of multi-dose or unit dose vials by trapping aerosols released when the access needle is withdrawn from the septum, the use of this separate component, along with the others needed to actually have a drug available to deliver, increased the cost and time of preparation.
Self-dispensing (i.e., piggy-back) bottles has been another heretofore suggested approach. Bottles of this type have normally contained only enough drug for a single dose, and the drug has usually been reconstituted using a separate source of diluent and preparative supplies. When the drug has been reconstituted in such a bottle, the bottle itself has then served as the dispensing reservoir for the dose, with such dispensing being normally under gravity flow.
A variation of the self-dispensing bottle approach, that has also been heretofore suggested was a soft bag pre-filled with a dry drug. While having the same general objective, a diluent dispenser has been utilized to speed up the process of filling the bag for reconstitution.
A still different approach heretofore suggested was utilization of a partial-fill bag wherein the bag contains diluent. Separate supplies have normally been used to reconstitute the drug, which was then added to the partially filled bag, to make a unit dose. In a sophistication of this approach, a dry drug vial has been utilized with the vial attached to a special partial-fill bag to eliminate the need for preparation supplies and extra diluent.
To save preparation time, it has also been suggested that bags be provided that are pre-filled with drug solution, usually to be stored frozen. Another unit dose pre-fill approach that has been suggested was a pre-filled syringe cartridge which contains drug solution. A drug pre-fill has also been suggested containing a drug which could be inserted into a special patient-activated delivery pump.
All of the unit dose approaches, however, have had the clear limitation of being applicable only to those drugs which are given in the same dose (i.e., quantity of drug), or within a very small range of doses, to most patients. It can therefore be appreciated that multi-dose packaging, on the other hand, can present substantial advantages if the contents can be custom-dispensed without significant labor input.
A major problem with any liquid pre-fill, however, regardless of whether delivery is intended as a unit dose or a multi-dose, is that such pre-fills have heretofore been commonly limited either to those drugs which are stable at room temperatures or are frozen. This can be overcome, however, by the use of dry or binary (dry chamber plus diluent chamber) packaging forms, since such packaging allows continued separation of the drug components until near the time of use, at which time the components can be mixed and dispensed. This clearly is advantageous, particularly where the components should not (or perhaps in some cases cannot) be mixed until quite near the time of intended use, such as, for example, where the reconstituted drug has a short shelf-life.
With respect to prior art patents, U.S. Pat. No. 3,938,520 is directed to a mixing device having a vented transfer unit wherein the contents of a medicament storage receptacle can be mixed with the contents of a diluent storage receptacle with the lower positioned diluent storage receptacle being vented through the transfer unit positioned above the diluent storage unit, and with a syringe being mentioned for withdrawal of the mixture from the diluent stage receptacle, while still in the upright position, through the transfer unit.
U.S. Pat. No. 3,125,092 is directed to a device for supplying an additive material to a solution in an infusion flask by withdrawing solution from the infusion flask through a needle using a rubber ball positioned between the needle and container holding the additive material, mixing the withdrawn solution with additive material in the additive container, and then exerting positive pressure to return the mixture through the needle to the infusion flask.
U.S. Pat. No. 4,410,321 is directed to a closed drug delivery system wherein the diluent is within a bag and is mixed at the bag with a substance stored in a separate container prior to use.
U.S. Pat. No. 3,337,041 is directed to a disposable syringe wherein material, in solid state within the syringe, is mixed in the syringe with liquid material withdrawn from a storage receptacle by insertion of the nozzle end of the syringe into the storage receptacle.
U.S. Pat. No. 1,929,616 is directed to a double compartment ampule wherein two substances are mixed within the ampule by repositioning a divider between the compartments separately storing the substances.
U.S. Pat. No. 3,881,640 is directed to a measuring means for reconstituted substances with the device having an air vent filter connected therewith for venting air from the top portion of the measuring means. U.S. Pat. No. 3,938,520, discussed above, also includes a filter included in the air vent passage above the receptacle being vented.
As can be appreciated from the foregoing, while various devices and methods have heretofore been suggested and/or utilized for handling of various substances, including handling of drugs with mixing of such drugs being included in such handling, such devices and methods have not proved to be completely successful, at least in some cases, in providing a device and method for handling substances, such as drugs, particularly where such drugs are to be used in individualized doses, are to be mixed just prior to use, and/or are to be prepared and utilized with minimum labor, minimum chance of error occurrence, and maximum safety.